Evaluation of a mailed self-collection device to screen for high-risk HPV infection in under-screened women in North Carolina

BACKGROUND: About half of new U.S. cases of invasive cervical cancer are attributable to insufficient screening. Mailing at-home self-collection kits for HPV testing to high-risk women is a promising strategy to increase screening in hard-to-reach populations. OBJECTIVE: To test the validity and acceptability of a mailed self-collection HPV device among women not recently screened for cervical cancer, compared to clinic-based self- and clinician collection. METHODS: Study participants were low-income women aged 30 to 64 and unscreened for cervical cancer in 4 or more years (overdue by current recommendations). Participating women were asked to self-collect a cervical/vaginal sample at home; return the sample by mail; visit a local clinic for a second self-collected sample and physician-collected endocervical sample; and complete a questionnaire by phone. All self- and physician-collected samples were tested for high-risk (oncogenic) HPV mRNA. Physician-collected samples were also tested for cervical abnormalities using liquid-based cytology. RESULTS: Among 155 women recruited to date, most participants were white (70%) or African-American (21%), with median annual household income below $10,000. Most women returned self-collection kits (83%), completed clinic appointments (74%), and reported feeling mostly positive or neutral about self-collection (97%). High-risk HPV mRNA was detected in 12% of women, cervical abnormalities in 11%, and histologically confirmed CIN2+ (high-grade precancerous lesions) in 3%. Among participants with abnormal cytology, HPV results from home self-collection had 100% concordance with clinician collection. CONCLUSIONS: Home-based cervico-vaginal self-collection for HPV mRNA testing appears to be a well-accepted and clinically valid method of detecting high-risk HPV infection.